BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3130911 · Received May 24, 2013

    Report

    Report Number
    1061932-2013-00868
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUES PRIOR TO THE SERVICE VISIT. THE CUSTOMER REPORTED NOTICING A DISCONNECTED TUBING AT THE BOTTOM OF VACUUM CHAMBER VC12 (SHEATH FLOW RESTRICTOR) AND PROCEEDED TO RECONNECT THE TUBING. THE CUSTOMER STATED THAT THE LEAK AND SHEATH TANK ERRORS WERE RESOLVED. FAILURE MODE IS RELATED TO A DISCONNECTED TUBING AT VACUUM CHAMBER VC12 AND ISSUES WERE RESOLVED BY THE CUSTOMER BY REATTACHING THE DISCONNECTED TUBING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DILUENT LEAK OF APPROXIMATELY 3 ML FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THE INSTRUMENT GENERATED SHEATH TANK ERRORS AT THE TIME OF THE LEAK. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231436 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1